País: Canadá
Língua: inglês
Origem: Health Canada
ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)
SANIS HEALTH INC
C10AA05
ATORVASTATIN
10MG
TABLET
ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 10MG
ORAL
500
Prescription
HMG-COA REDUCTASE INHIBITORS
Active ingredient group (AIG) number: 0133055001; AHFS:
APPROVED
2012-12-18
_ATORVASTATIN (atorvastatin calcium) _ _ _ _ _ _ _ _ _ _ _ _ Page 1 of 55 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR ATORVASTATIN Atorvastatin Calcium Tablets Tablet, 10 mg, 20 mg, 40 mg and 80 mg atorvastatin (as atorvastatin calcium propylene glycol solvate), Oral USP Lipid Metabolism Regulator Sanis Health Inc. 1 President's Choice Circle Brampton, Ontario L6Y 5S5 Date of Initial Authorization: July 30, 2020 Date of Revision: August 22, 2022 Submission Control Number: 265202 _ATORVASTATIN (atorvastatin calcium) _ _ _ _ _ _ _ _ _ _ _ _ Page 2 of 55 _ RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS 08/2022 7 WARNINGS AND PRECAUTIONS, Musculoskeletal 08/2022 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES ...................................................................................... 2 TABLE OF CONTENTS ........................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ............................................................... 4 1 INDICATIONS .................................................................................................................... 4 1.1 Pediatrics ......................................................................................................... 4 1.2 Geriatrics .......................................................................................................... 5 2 CONTRAINDICATIONS ..................................................................................................... 5 4 DOSAGE AND ADMINISTRATION ................................................................................... 5 4.1 Dosing Considerations ....................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment .......................................................... 6 4.4 Administration ........................................... Leia o documento completo